Penetrating antibiotic gel for soft tissue diseases

Abstract

A penetrating antibiotic gel for treating pain, inflammation and other pathological conditions affecting musculoskeletal tissues and other soft tissues of the body. The composition includes an antibiotic compound and a mobilizing agent in an amount sufficient to enable the antimicrobial compound to penetrate into the sub-dermal soft tissues. The antimicrobial compound may be a macrolide antibiotic compound such as azithromycin, erythromycin or roxithromycin, for example, and the mobilizing agent may be an organogel compound, such as pluronic lecithin liposomal organogel (PLO). The composition may further include a penetration enhancing adjuvant, such as d-limonene, for example. The composition may be applied topically so as to penetrate into the sub-dermal soft tissues, or may injected so as to be absorbed into the soft tissues locally.

1. A method for alleviating a disease state resulting from a microbial infection affecting musculoskeletal soft tissue, said method comprising the steps of:
 determining a localized area of a patient's body in which affected musculoskeletal soft tissue is located; providing a treatment composition comprising, in combination:  
 (i) a selected macrolide antibiotic; and  
 (ii) a selected mobilizing agent in an amount sufficient to enable said macrolide antibiotic to penetrate into said musculoskeletal soft tissue; and applying said treatment composition to said localized area of said patient's body so that said macrolide antibiotic penetrates said affected musculoskeletal soft tissue so as to reach said microbial infection therein.  
 
     
     
       2. The method of  claim 1 , wherein the step of applying said treatment composition comprises:
 applying said treatment composition topically to a skin area overlying said musculoskeletal soft tissue in said predetermined area of the body.  
 
     
     
       3. The method of  claim 1 , wherein the step of applying said treatment composition comprises:
 applying said treatment composition by hypodermic injection into said musculoskeletal soft tissue in said area of the body.  
 
     
     
       4. The method of  claim 1 , wherein said treatment composition further comprises:
 a penetration enhancing adjuvant.  
 
     
     
       5. The method of  claim 4 , wherein said penetration enhancing adjuvant comprises d-limonene. 
     
     
       6. A method of alleviating a disease state resulting from a microbial infection affecting sub-dermal soft tissue in a predetermined area of the body, said method comprising the steps of:
 Providing a treatment composition comprising, in combination: 
 (i) a macrolide antibiotic macrolide antibiotic selected from the group consisting of azithromycin, erythromycin and roxithromycin; and  
 (ii) PLO gel in an amount sufficient to enable said macrolide antibiotic to penetrate into said sub-dermal soft tissue; and  
 
 applying said treatment composition to said predetermined area of the body so that said macrolide antibiotic penetrates said sub-dermal soft tissues so as to reach said microbial infection therein.  
 
     
     
       7. The method of  claim 6 , wherein said treatment composition further comprises:
 a penetration enhancing adjuvant.  
 
     
     
       8. The method of  claim 7 , wherein said penetration enhancing adjuvant comprises d-limonene. 
     
     
       9. A method for alleviating a disease state resulting from a microbial infection affecting sub-dermal soft tissue in a predetermined area of the body, said method comprising the steps of:
 providing a treatment composition comprising, in combination: 
 (i) a selected macrolide antibiotic;  
 (ii) a selected mobilizing agent in an amount sufficient to enable said macrolide antibiotic to penetrate into said sub-dermal soft tissue; and  
 (iii) a penetration enhancing adjuvant comprising limonene; and  
 
 applying said treatment composition to said predetermined area of the body so that said macrolide antibiotic penetrates said sub-dermal soft tissue so as to reach said microbial infection therein.  
 
     
     
       10. The method of  claim 9 , wherein the step of applying said treatment composition comprises:
 applying said treatment composition topically to a skin area overlying said sub-dermal soft tissue in said predetermined area of the body.  
 
     
     
       11. The method of  claim 9 , wherein the step of applying said treatment composition comprises:
 applying said treatment composition by injection into said sub-dermal soft tissue in said area of the body.  
 
     
     
       12. The method of  claim 9 , wherein the step of providing said treatment composition comprises:
 selecting said macrolide antibiotic from the group consisting of azithromycin, erythromycin and roxithromycin.  
 
     
     
       13. The method of  claim 12 , wherein said mobilizing agent comprises a gel compound. 
     
     
       14. The method of  claim 13 , wherein said gel compound is PLO gel. 
     
     
       15. A treatment composition for alleviating a disease state resulting from a microbial infection affecting musculoskeletal soft tissue in a predetermined area of the body, said treatment composition comprising:
 (i) a macrolide antibiotic selected from the group consisting of azithromycin, erythromycin and roxithromycin; and  
 (ii) PLO gel in an amount sufficient to enable said macrolide antibiotic to penetrate into said musculoskeletal soft tissue so as to reach said microbial infection therein when said composition is applied to said predetermined area of the body.  
 
     
     
       16. The treatment composition of  claim 15 , further comprising:
 (iii) a selected penetration enhancing adjuvant for increasing penetration of said musculoskeletal soft tissue in said predetermined area of the body.  
 
     
     
       17. The treatment composition of  claim 16 , wherein said penetration enhancing adjuvant comprises d-limonene. 
     
     
       18. A treatment composition for alleviating pain and inflammation resulting from a microbial infection affecting sub-dermal musculoskeletal tissue in a predetermined area of the body, said treatment composition comprising:
 (i) a macrolide antibiotic compound selected from the group consisting of azithromycin, erythromycin and roxithromycin; and  
 (ii) PLO gel in an amount sufficient to enable said macrolide antibiotic compound to penetrate into said sub-dermal soft tissue so as to reach said microbial infection therein when said composition is applied topically to said predetermined area of the body.  
 
     
     
       19. The treatment composition of  claim 18 , wherein said macrolide antibiotic compound is present in said composition in an amount in the range from about 50 mg/cc of PLO gel to about 3 gm/cc of PLO gel. 
     
     
       20. The treatment composition of  claim 19 , wherein said macrolide antibiotic compound is azithromycin. 
     
     
       21. The treatment composition of  claim 20 , wherein said azithromycin is present in said composition in an amount of about 250 mg/cc of PLO gel. 
     
     
       22. The treatment composition of  claim 18 , further comprising:
 a selected penetration enhancing adjuvant for increasing penetration of said macrolide antibiotic compound into said sub-dermal soft tissue.  
 
     
     
       23. The treatment composition of  claim 22 , wherein said penetration enhancing adjuvant comprises d-limonene. 
     
     
       24. A treatment composition for alleviating a disease state resulting from a microbial infection affecting musculoskeletal soft tissue in a predetermined area of the body, said treatment composition comprising:
 (i) azithromycin; and  
 (ii) PLO get in an amount sufficient to enable said azithromycin to penetrate into said soft tissue so as to reach said microbial infection therein when said composition is applied to said predetermined area of the body.  
 
     
     
       25. The treatment composition of  claim 24 , further comprising:
 a selected penetration enhancing adjuvant for increasing penetration of said sub-dermal soft tissue in said predetermined area of the body.  
 
     
     
       26. The treatment composition of  claim 25 , wherein said penetration enhancing adjuvant comprises d-limonene. 
     
     
       27. A treatment composition for alleviating a disease state resulting from a microbial infection affecting sub-dermal soft tissue in a predetermined area of the body, said treatment composition comprising:
 (i) a selected macrolide antibiotic;  
 (ii) a selected mobilizing agent in an amount sufficient to enable said macrolide antibiotic to penetrate into said sub-dermal soft tissue so as to reach said microbial infection therein when said composition is applied to said predetermined area of the body; and  
 (iii) a selected penetration enhancing adjuvant for increasing penetration of said sub-dermal soft tissue in said predetermined area of the body, said penetration enhancing adjuvant comprising d-limonene.  
 
     
     
       28. The treatment composition of  claim 27 , wherein said macrolide antibiotic composition is selected from the group consisting of azithromycin, erythromycin and roxithromycin. 
     
     
       29. The treatment composition of  claim 28 , wherein said macrolide antibiotic compound is azithromycin. 
     
     
       30. The treatment composition of  claim 28 , wherein said mobilizing agent comprises a selected organogel compound. 
     
     
       31. The treatment composition of  claim 30 , wherein said organogel compound is PLO gel.